复黄片_____]_复黄片;_临床研究;

从复黄片的临床研究谈谈中药临床试验的设计与质量控制

http://www.100md.com 《中西医结合学报》 2005年第3期

复黄片,,],复黄片;,临床研究;,研究设计;,质量控制,1资料与方法,2结果,3讨论,[参考文献]

     [摘要] 目的：通过临床试验评价复黄片治疗内痔出血的效果，并讨论其研究设计与质控。方法：144例内痔出血病例按双中心随机盲法阳性药物对照试验设计分成2组。复黄片治疗组72例，口服复黄片4粒/次，3次/d；痔宁片对照组72例，口服痔宁片4粒/次，3次/d。治疗第3和第7天时观察患者的症状体征等变化，评价其疗效。结果：治疗第3天时，复黄片组总有效率58.57%，痔宁片组总有效率27.78%，两者比较有统计学差异(P<0.05)。治疗第7天时，复黄片组总有效率91.43%，痔宁片组总有效率81.94%，两者比较无统计学差异。两组治疗前后实验室指标及生命体征都在正常范围。结论：复黄片是一种治疗内痔便血安全、有效的口服制剂。

    [关键词] 复黄片; 临床研究; 研究设计; 质量控制

    Discussion on design and quality control of clinical trials of traditional Chinese medicine on the basis of Fuhuang Tablets clinical study

    LU JinGen1, PAN YiBin1, CAO YongQing1, YANG Wei2, ZHANG XinLin3

    (1.Shanghai Municipal Clinical Medicine Center for Chinese Traditional Surgery, Shanghai 200032, China; 2.Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021; 3.Department of Anorectal Surgery, Shanghai Hospital of Traditonal Chinese Medicine, Shanghai 200071, China)

    ABSTRACT Objectives: To assess the efficacy of Fuhuang Tablets in treating internal hemorrhoid hemorrhage and discussing the design and quality control of clinical trials of traditional Chinese medicine. Methods: According to twocenter, randomized, blinded and controlled study, 144 patients with internal hemorrhoids were divided into 2 groups. Seventytwo patients were treated with Fuhuang Tablets (4 tablets t.i.d. per os) and the other 72 patients were treated with Zhining Tablets (4 tablets t.i.d. per os). Symptoms and signs of the patients were recorded and evaluated at the third and seventh day of treatment respectively. Results: At the third day of treatment, the overall response rates of Fuhuang Tabletstreated group and Zhining Tabletstreated group were 58.57% and 27.78% respectively, with statistic difference between the two groups (P<0.05). At the seventh day of treatment, the overall response rates of Fuhuang Tabletstreated group and Zhining Tabletstreated group were 91.43% and 81.94% respectively, with no statistic difference between the two groups. The laboratory test results and life signs of the 144 patients were normal before and after the treatment. Conclusion: Fuhuang Tablets are effective and safe in treating internal hemorrhoid hemorrhage. ......

百拇医药网 http://www.100md.com/html/DirDu/2006/06/10/00/72/40.htm

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